CN108430387B

CN108430387B - Stent graft with external support

Info

Publication number: CN108430387B
Application number: CN201780004993.1A
Authority: CN
Inventors: K·帕金斯; J·阿根泰恩; M·彼特鲁斯卡; S·罗巴伊纳; D·加利甘; R·拉达克里什南
Original assignee: Medtronic Vascular Inc
Current assignee: Medtronic Vascular Inc
Priority date: 2016-02-12
Filing date: 2017-02-10
Publication date: 2021-02-12
Anticipated expiration: 2037-02-10
Also published as: EP3413837B1; CN108430387A; WO2017139545A1; US20190110884A1; US10188500B2; US20170231749A1; EP3413837A1

Abstract

A supported stent graft includes a graft material having an inner surface and an outer surface. The inner surface defines a cavity within the graft material. The supported stent graft also includes a scaffold having a mesh coupled to an outer surface of the graft material. The scaffold is configured to promote ingrowth of tissue therein. Thus, the scaffold enhances integration of tissue into the stented stent graft. This tissue integration enhances the biological fixation of the stent graft within the vessel, minimizing the possibility of endoleaks and migration.

Description

Stent graft with external support

Background

Technical Field

The present application relates to intravascular devices and methods. More particularly, the present application relates to devices for treating intravascular conditions.

Background

Conventional stent grafts typically have a radially expandable reinforcing structure comprised of a plurality of annular stent rings and a cylindrical layer of graft material forming a lumen over which the stent rings are coupled. Stent grafts are well known for use in tubular human vessels.

For example, aneurysm endoluminal isolation is a method of using a stent graft to relieve the pressure of fluid inside an aneurysm, thereby reducing the risk of aneurysm rupture and reducing invasive surgical intervention.

The graft material of conventional stent grafts is extremely hydrophobic and the environment it provides is not conducive to the recruitment and proliferation of cells. Biological fixation of the stent graft within the vessel is not achieved due to the inability of tissue to integrate within the graft material, resulting in a stent graft that is prone to endoleak and migration.

Summary of The Invention

According to one embodiment, a stent graft comprises a graft material having an inner surface and an outer surface. The inner surface defines a cavity within the graft material. The stented graft further includes a scaffold (scaffold) having a mesh coupled to an outer surface of the graft material.

The scaffold is configured to promote tissue ingrowth therein. Thus, the scaffold enhances integration of tissue into the stented stent graft. The tissue integration enhances the biological fixation of the stent graft within the vessel, minimizing the possibility of endoleak and migration.

Drawings

Figure 1 is a perspective view of one of the supported stent graft embodiments.

Figure 2 is a cross-sectional view of one of the embodiments of the supported stent graft of figure 1.

Fig. 3A is an enlarged view of one embodiment of the region III of the supportive stent graft of fig. 2.

Fig. 3B is an enlarged view of another embodiment of the region III of the supportive stent graft of fig. 2.

Figure 4 is a cross-sectional view of a vascular assembly including one of the embodiments of the supported stent graft of figures 1 and 2.

Figure 5 is a perspective view of another embodiment of a stent graft.

Figure 6 is a cross-sectional view of one of the embodiments of the supported stent graft of figure 5.

Figure 7 is a cross-sectional view of a vascular assembly including one of the embodiments of the supported stent graft of figures 5 and 6.

Figure 8 is a perspective view of another embodiment of a supported stent graft.

Figure 9 is a cross-sectional view of one of the embodiments of the supported stent graft of figure 8.

Figure 10 is a cross-sectional view of a vascular assembly including one of the embodiments of the supported stent graft of figures 8 and 9.

Like elements are numbered uniformly throughout the drawings and the specification.

Detailed Description

As one of an overview and an embodiment, a stent graft includes a graft material and an outer scaffold. The graft material provides a barrier to tissue integration. The outer scaffold is preferably adapted to promote tissue integration and mechanical attachment to the graft material. Tissue enters the outer scaffold to form a biological fixation with the native vessel, thereby minimizing the possibility of endoleaks and dislodgement.

More specifically, fig. 1 is a perspective view of a supported stent graft 100, which may be, for example, an abdominal aortic stent graft, as one embodiment. As shown in fig. 1, a supported stent graft 100 has one or more stent rings 102. By way of illustration, the stent ring 102 is a self-expanding stent ring, such as that of nickel titanium alloy (NiTi), sometimes referred to as Nitinol (Nitinol). The stent ring 102 is optional and one embodiment does not include a stent ring 102.

Fig. 2 is a cross-sectional view of the supported stent graft 100 of fig. 1 in one of the embodiments. In fig. 2, the stent ring 102 is not shown for clarity.

Fig. 1 and 2 jointly show a supported stent graft 100 having a graft material 104 and a scaffold 106. In this embodiment, graft material 104 has a proximal opening 108 at a proximal end 110 of graft material 104 and a distal opening 112 at a distal end 114 of graft material 104.

Also, the supporting stent graft 100 has a long axis L. Graft material 104, generally a stent graft 100, defines a lumen 116. The extension of lumen 116, which is generally parallel to the long axis L, extends between proximal opening 108 and distal opening 112 of the supported stent graft 100.

Herein, the proximal end of a prosthesis (e.g., a stent graft) is the end closest to the heart via the blood flow path, while the distal end is the end furthest from the heart when deployed. Conversely, it should be noted that the distal end of the catheter is generally the end furthest from the operator (handle), while the proximal end of the catheter is the end closest to the operator (handle).

For clarity, herein, the distal end of the catheter is the end furthest from the operator (the end furthest from the handle) and the distal end of the prosthesis is the end closest to the operator (the end closest to the handle), i.e. the distal end of the catheter and the proximal end of the stent-graft are the ends furthest from the handle, and the proximal end of the catheter and the distal end of the stent-graft are the ends closest to the handle. However, those skilled in the art will appreciate that in practice, the descriptions of the stent graft and delivery system may be the same or reversed, depending on the access location.

The graft material 104 is cylindrical in shape and has a substantially uniform diameter D. However, in other embodiments, the graft material 104 may vary in diameter and/or diverge at the distal end 114. The graft material 104 has a cylindrical inner surface 118 and an opposite outer surface 120.

In one embodiment, the graft material 104 is hydrophobic, such as a terephthalate-type Polyester (PET), an expanded terephthalate-type polyester (ePET), or other graft material. Because the graft material 104 is hydrophobic, the graft material 104 provides an environment that is not conducive to cell recruitment and proliferation.

In one embodiment, to enhance tissue integration, the scaffold 106 is attached to the outer surface 120 of the graft material 104 by attachment means 122. By way of illustration, the attachment means/means 122 is a stitching, adhesive, heat seal, or other attachment between the scaffold 106 and the graft material 104.

In this embodiment, scaffold 106 is attached to graft material 104 at or adjacent to proximal end 110 of graft material 104. A region 124 of the graft material 104 is covered by the scaffold 106, referred to as a sealed region 124 of the graft material 104. A region 126 of the graft material 104 not covered by the scaffold 106 is referred to as an exposed region 126 of the graft material 104. The sealing region 124 extends distally from the proximal end 110 to an exposed region 126. The exposed region 126 extends distally from the sealed region 124 to the distal end 114.

In this embodiment, the support frame 106 is a mesh. In one embodiment, the mesh is a staggered or solid structure defining a plurality of openings 128 therein. For example, a mesh of wires or filaments may be interlaced (e.g., braided) to form the cage 106 with openings 128. In another embodiment, the tube or sheet material is laser cut to form the opening 128 therein such that the support frame 106 is unitary, i.e., one piece rather than a combination of multiple pieces.

In one embodiment, the openings 128 in the scaffold 106 are optimized to promote maximum tissue integration. In one embodiment, the opening 128 is completely surrounded by the support frame 106, i.e., a discrete opening. The scaffold 106 is sometimes referred to as a tissue integration scaffold 106.

In one embodiment, the support frame 106 is a metallic material. For example, the support frame 106 is formed from nitinol, but other embodiments may be formed from other metallic materials. In another embodiment, the scaffold 106 is a polymeric material. In general, the material used to form the scaffold 106 supports good tissue integration and uptake into the vessel wall at the site of implantation of the stent graft 100.

In one embodiment, the scaffold 106 is physically coupled to the graft material 104, for example, using a suture technique. In this way, the mechanical advantage of the integration of the scaffold 106 into the vessel wall translates directly into an enhanced anti-migration and sealing effect of the stent graft 100.

In this embodiment, the support frame 106 is cylindrical. The scaffold 106 is flexible and of sufficiently low profile so as not to significantly affect the packing density of the stented stent graft 100.

Fig. 3A is an enlarged view of one of the embodiments of region III of the supported stent graft 100 of fig. 2. As shown in FIG. 3A, in this embodiment, the scaffold 106 has tissue reaction enhancing fibers 330 embedded therein. For example, the scaffold 106 has a scaffold body 332, such as formed from a mesh of metallic or polymeric material as described above, and tissue-reactive reinforcing fibers 330 embedded within the scaffold body 332. The tissue response enhancing fibers 330 are sometimes referred to as bioactive material fibers.

Tissue response enhancing fibers 330 enhance the tissue response (tissue response) of the tissue with the stent graft 100. In one embodiment, the tissue response enhancing fibers 330 comprise a material that promotes tissue healing, sometimes referred to as a buttress material. The tissue response enhancing fibers 330 contain materials that promote tissue healing, for example, promote the recruitment or proliferation of cells that promote the healing process. Examples of the tissue response enhancing fiber 330 containing a material that promotes tissue healing include polyglycolic-lactic acid (PGLA), poly (glycerol sebacate) (PGS), animal derived decellularized scaffolds, collagen scaffolds, and other materials that promote tissue healing.

In another embodiment, the tissue response enhancing fibers 330 contain a tissue irritating material that actively promotes an inflammatory response that causes a strong fibrocellular response (fibrocyte response). Examples of irritating materials in the tissue response enhancing fibers 330 include PGLA, polyglycolic acid (PGA), polylactic acid (PLA), silk, bacterial endotoxin, and other irritating materials.

In another embodiment, the tissue response enhancing fibers 330 contain an absorbable polymer material that allows for elution of bioactive molecules that promote rapid healing and/or promote thrombosis/maturation. Examples of bioactive molecules include drugs, peptides, cytokines/chemokines.

Fig. 3B is an enlarged view of another embodiment of region III of the supported stent graft 100 of fig. 2. As shown in fig. 3B, in this embodiment, the scaffold 106 has a tissue response enhancing coating 334. For example, the scaffold 106 includes a scaffold body 332 and a tissue reaction enhancing coating 334 coated on or impregnated into the scaffold body 332. The tissue response enhancing coating 334 enhances tissue reaction with the supported stent graft 100 in a manner similar to the tissue response enhancing fibers 330 described previously. Tissue reaction enhancing coating 334 is sometimes referred to as a bioactive material coating.

More particularly, tissue response enhancing coating 334 contains a material such as a material that promotes tissue healing or a stimulating material. In one embodiment, tissue response enhancing coating 334 comprises a material that promotes tissue healing, such as cell recruitment or proliferation that promotes the healing process. Examples of tissue healing promoting materials in tissue response enhancing coating 334 include PGLA, PGS, animal derived acellular scaffolds, gelatin scaffolds, and other tissue healing promoting materials.

In another embodiment, the tissue response enhancing coating 334 contains a tissue irritating material that actively promotes an inflammatory response that elicits a strong fibrocyte response. Examples of irritating materials in the tissue response enhancing coating 334 include PGLA, PGA, PLA, silk, bacterial endotoxins, and other irritating materials.

In another embodiment, tissue response enhancing coating 334 contains an absorbable polymer material that allows for elution of bioactive molecules that promote rapid healing and/or promote thrombosis/maturation. Examples of bioactive molecules include drugs, peptides, cytokines/chemokines.

Fig. 4 is a cross-sectional view of a vascular assembly 400 including one of the embodiments of the supported stent graft 100 shown in fig. 1 and 2. As shown in fig. 4, a blood vessel 402 (e.g., the aorta) has an aneurysm 404. Deployment of the stented stent graft 100 within the vessel 402 isolates the aneurysm 404 using any of a number of techniques well known to those skilled in the art.

Branching from vessel 402 is a first branch 406 and a second branch 408, sometimes referred to as abdominal aortic visceral branches. The location of the

branch vessels

406, 408 varies from person to person in the patient. Examples of branch vessels include the Renal Artery (RA) and Superior Mesenteric Artery (SMA).

The location at which the supported stent graft 100 is deployed is just distal to the

branch vessels

406 and 408. The scaffold 106, i.e., the sealing zone 124, is deployed at a landing zone 410 between the

branch vessels

406, 408 and the aneurysm 404. Over time, the tissue of the blood vessel 402 will integrate with the scaffold 106, thereby avoiding leakage around the sealing zone 124 and dislodgement of the stented stent graft 100.

Parking zone 410 is sometimes referred to as proximal seal zone 410. While the proximal seal 410 is described herein, it will be appreciated by those skilled in the art that the cage 106 may be generally deployed in any seal, including, for example, the distal seal, as will be appreciated by those skilled in the art.

After anchoring within vessel 402, blood flows through lumen 116, more generally through stent graft 100, thereby isolating aneurysm 404.

Fig. 5 is a perspective view of another embodiment supported stent graft 500. Fig. 6 is a cross-sectional view of the supported stent graft 500 of fig. 5 according to one of the embodiments. In fig. 6, the stent ring 102 is not shown for clarity. The supported stent graft 500 shown in fig. 5 and 6 is similar to the supported stent graft 100 shown in fig. 1 and 2 with only the significant differences described below.

Fig. 5 in conjunction with fig. 6 shows a stent graft 500 having graft material 104, a scaffold 506, and a scaffold counter-scaffold loop 508.

In one embodiment, to enhance tissue integration, the scaffold 506 is attached to the outer surface 120 of the graft material 104 by attachment means 122. In this embodiment, scaffold 506 is attached to graft material 104 at or adjacent to proximal end 110 of graft material 104. A region 124 of the graft material 104 is covered by a scaffold 506, also referred to as a sealing region 124 of the graft material 104. The area 126 of the graft material 104 not covered by the scaffold 506 is also referred to as the exposed area 126 of the graft material 104.

In this embodiment, the material forming the scaffold 506 is the same as previously described with respect to scaffold 106, including a metallic material, a polymeric material, tissue reaction enhancing fibers 330, a scaffold body 332, a tissue reaction enhancing coating 334, and/or any combination thereof. The metal to artery ratio of the scaffold 506 is optimized to cause blood stasis that causes thrombosis to help promote an acute seal (acute seal). In one embodiment, the scaffold 506 has a metal to artery ratio greater than about 30-40%, and other embodiments may use other metal to artery ratios.

In this embodiment, the support 506 is in the form of a torus (torus), for example shaped like a doughnut. The support frame 506 is sometimes also referred to as a tubular mesh, e.g., a thin flexible mesh having a density that does not adversely affect the packing. The scaffold 506 is flat when packaged in the delivery system in order to reduce the effect on packing density of the delivery system, but will be formed into a tube at, for example, 37 ℃. It is noted that in fig. 5 and 6, the scaffold 506 is shown in an expanded form, which is in a collapsed state during delivery.

As the scaffold 506 expands into a tubular shape, the scaffold 506 exerts an inward radial collapsing force on the graft material 104. To resist this force and avoid collapse of the graft material 104, a scaffold is coupled against the scaffold loop 508, sometimes referred to as a scaffold graft body spring, at a location directly opposite the scaffold 506 from the interior surface 118 of the graft material 104. The cage provides an outward radial expansion force against the cage ring 508 that is greater than an inward radial collapse force of the cage 506. Thus, the scaffold is protected against the scaffold loop 508 from the graft material 104 collapsing due to the scaffold 506. In one embodiment, the cage may be soft and thin against the cage ring 508 due to the inertia of the cage 506 to conform to blood pressure.

Although only one cage counter-cage ring 508 is shown, in other embodiments, there may be more than one cage counter-cage ring 508. Also, in another embodiment, the inward radial collapse force of the scaffold 506 on the graft material 104 is less than the diastolic pressure, e.g., the scaffold 506 has a "soft" configuration. In this embodiment, the cage is not necessary to oppose the cage ring 508, and it is not present. The geometric design is such that: the stent graft 500 can hold its shape with the blood flow even if there is no stent against the stent rings 508.

In one embodiment, the scaffold 506 is filled or coated with a swelling material 510, such as a hydrogel. For example, the swelling material 510 swells when contacted by a liquid (e.g., blood). The expansion of the swelling material 510 further enhances the sealing of the stent graft 500 within the vessel as described below in connection with fig. 7.

Figure 7 is a cross-sectional view of a vascular assembly 700 including one of the embodiments of the supported stent graft 500 shown in figures 5 and 6. As shown in fig. 7, the vascular assembly 700 is similar to the vascular assembly 400 of fig. 4, including a blood vessel 402, an aneurysm 404, and

branch vessels

406, 408. Deployment of the stented stent graft 500 within the vessel 402 isolates the aneurysm 404 using any of a number of techniques well known to those skilled in the art.

In this embodiment, the neck 710 of the aneurysm 404 is shorter in length. The neck 710 is the region between the aneurysm 404 and the

branch vessels

406, 408, sometimes referred to as the proximal sealing region 710. For example, the neck 710 is 10mm or less in length, and therefore may be referred to as a short neck 710. As shown in fig. 7, the diameter of the neck 710 increases with distance from the

branch vessels

406, 408. Due to the tapered shape of the neck 710, the neck 710 is sometimes referred to as a tapered neck 710.

Although a tapered short neck 710 is shown in fig. 7 and described below, it will be appreciated by those skilled in the art from the disclosure herein that the stent-graft 500 may be deployed in any vessel regardless of the length and shape of the aneurysm neck. Also, while the proximal seal 710 is described herein, it will be appreciated by those skilled in the art that the cage 506, in general, may be deployed within any seal, including, for example, the distal seal.

As shown in fig. 7, the cage 506 is spread out to contact the wall of the neck 710. The radial force provided by the scaffold 506 causes the scaffold 506 to stabilize the stent-graft 500 within the aneurysm 404 void. Also, the scaffolding 506 causes blood stagnation, forming a thrombus that promotes acute sealing of the stent-graft 500 to the blood vessel 402. The scaffolding 506 quickly integrates into the wall of the blood vessel 402, thereby providing a permanent enhanced seal and resistance to displacement. The support bracket 506 is particularly well suited for attachment to a high angle neck region, such as neck 710.

Once anchored within vessel 402, blood flows through lumen 116, more generally through stent graft 500, thereby isolating aneurysm 404.

In another embodiment, as shown in fig. 7, the scaffold 506 has a proximal section 507 extending proximally from the proximal end 110 of the graft material 104 and beyond the

branch vessels

406, 408. In this embodiment, the scaffolding 506 is sufficiently porous so as not to occlude the

branch vessels

406, 408.

Fig. 8 is a perspective view of another embodiment supported stent graft 800. Figure 9 is a cross-sectional view of one of the embodiments of the supported stent graft 800 of figure 8. In fig. 9, the stent ring 102 is not shown for clarity. The supported stent graft 800 shown in fig. 8 and 9 is similar to 100 shown in fig. 1 and 2 with only the following significant differences.

Fig. 8 shows, in combination with fig. 9, a stent graft 800 having graft material 104, a scaffold 806, and a scaffold counter-scaffold loop 808.

In one embodiment, to enhance tissue integration, the scaffold 806 is attached to the outer surface 120 of the graft material 104 by attachment means 122. In this embodiment, the scaffold 806 is attached to the entire length of the graft material 104, generally between the proximal end 110 and the distal end 114.

In this embodiment, the scaffold 806 is formed from the same materials as described above with respect to scaffold 106, including a metallic material, a polymeric material, tissue reaction enhancing fibers 330, a scaffold body 332, a tissue reaction enhancing coating 334, and/or any combination thereof. The metal to artery ratio of the scaffold 806 is optimized to cause blood stagnation in the aneurysm sac to form a thrombus. In one embodiment, the scaffold 806 has a metal to artery ratio greater than about 30-40%, and other embodiments may use other metal to artery ratios.

In this embodiment, the support 806 is circular, e.g., shaped like a doughnut. The support frame 806 is sometimes referred to as a tubular mesh. The scaffold 806 is flat when packaged in the delivery system, e.g., collapsed around the graft material 104, in order to reduce the effect on the packing density of the delivery system, but is shaped as a tube at, e.g., 37 ℃. It is noted that in fig. 8 and 9, the scaffold 806 is shown in an expanded form, which is in a collapsed state during delivery.

As the scaffold 806 expands into a tubular shape, the scaffold 806 applies an inward radial collapsing force to the graft material 104. To resist this force and prevent the graft material 104 from collapsing, a scaffold is coupled to the interior surface 118 of the graft material 104 directly opposite the scaffold 806 against a scaffold ring 808, sometimes referred to as a stent graft body spring.

According to this embodiment, there are multiple scaffolding counter-scaffolding rings 808 along the length of the graft material 104. The scaffolding provides an outward radial expansion force against the scaffolding ring 808 that is greater than the inward radial collapse force of the scaffolding 806. Thus, the scaffold is protected against the scaffold loop 808 from the graft material 104 collapsing due to the scaffold 806. In one embodiment, the cage may be soft and thin against the cage ring 808 due to the inertia of the cage 806 in compliance with blood pressure.

Also, in another embodiment, the inward radial collapse force of the scaffold 806 applied to the graft material 104 is less than the diastolic pressure, e.g., the scaffold 806 has a "soft" structure. In this embodiment, the cage is not necessary to oppose the cage ring 808, which is not present. The geometric design is such that: the stent graft 800 can hold its shape with the blood flow even if the stent is not present against the stent ring 808.

In one embodiment, the scaffold 806 is filled or coated with a swelling material 810, such as a hydrogel. For example, the swelling material 810 swells when contacted by a liquid (e.g., blood). The expansion of the swelling material 810 further enhances the sealing of the stent graft 800 within the vessel as described below in connection with fig. 10.

In this embodiment, the supporting stent graft 800 has

extension portions

814, 816.

Extensions

814, 816 extend from distal end 114 of graft material 104. In one embodiment,

extensions

814, 816 are separate components (e.g., made of graft material) that are attached to graft material 104.

Extensions

814, 816 are sometimes also referred to as modular components. In another embodiment, the

extensions

814, 816 are integral with the graft material 104, e.g., a single piece of graft material is stitched or otherwise demarcated to define the

extensions

814, 816.

Extensions

814, 816 bifurcate main lumen 116 into

lumens

818, 820. For example,

extensions

814, 816 are deployed into the iliac arteries. However, in another embodiment, the supported stent graft 800 lacks the

extensions

814, 816. Also, the previously described supported

stent grafts

100, 500 may have

extensions

814, 816 of other embodiments.

Figure 10 is a cross-sectional view of a vascular assembly 1000 including one of the embodiments of the supported stent graft 800 of figures 8 and 9. As shown in fig. 10, the vascular assembly 1000 is similar to the vascular assembly 400 shown in fig. 4, including a blood vessel 402, an aneurysm 404, and

branch vessels

406, 408. In this embodiment, the vascular assembly 1000 also includes distal

iliac arteries

412, 414. Deployment of the stented stent graft 800 within the vessel 402 isolates the aneurysm 404 using any of a number of techniques well known to those skilled in the art.

In this embodiment, as shown in fig. 10, a scaffold 806 is deployed to fill the sac of the aneurysm 404. The scaffold 806 anchors the stented graft 800 in place as it is deployed within the aneurysm 404. This ensures sealing of the proximal seal area 410 and the distal seal area 1012 and prevents dislocation of the modular components (e.g., extensions 814, 816).

Also, the scaffold 806 causes blood to stagnate within the aneurysm 404, forming a thrombus. Clot formation within the aneurysm 404 minimizes the occurrence of type I and type II endoleaks. Also, the scaffold 806 quickly integrates into the wall of the vessel 402, providing a permanent enhanced seal and resistance to displacement.

As shown on the left side of the stented stent graft 800, in one embodiment, the aneurysm 404 is irregularly shaped, for example, with a ledge, thrombus within the aneurysm 404 capsule, and/or with one or more branch vessels 1016 extending thereto. In this embodiment, the scaffold 806 may have difficulty, if not impossible, actually contacting the blood vessel. The scaffolding 806 causes blood stasis and thrombosis to occlude the branch vessel 1016, thereby preventing the branch vessel 1016 from engorging the aneurysm 404 and avoiding type II endoleaks associated therewith.

Although a branch vessel 1016 is shown, the branch vessel 1016 represents all of the communication underlying the type II endoleak. For example, the presence of active communication between the Inferior Mesenteric Artery (IMA) and the lumbar arteries underlies type II endoleaks. This communication will occur throughout the network. The support frame 806 pushes thrombus out of the balloon blocking the passage. Once this communication is limited, the thrombus forms within a small cavity within the capsular thrombus. In one embodiment, the scaffold 806 contains thrombogenic materials to aid in intracapsular thrombosis.

After anchoring within vessel 402, blood flows through lumen 116, more generally through stent graft 800, thereby isolating aneurysm 404. In this embodiment, the

extensions

814, 816 are deployed within the

iliac arteries

412, 414.

Exemplary embodiments are provided herein. The exemplary embodiments are not to be construed as limiting in scope. Numerous variations, whether explicitly or implicitly described herein, such as variations in structure, dimension, and type of materials and manufacturing processes, may be implemented by those skilled in the art in light of the teachings herein.

Claims

1. A supported stent graft, having:

a hydrophobic graft material having an inner surface and an outer surface, the inner surface defining a cavity within the graft material, the graft material providing an environment that is not conducive to cell recruitment and proliferation; and

a scaffold having a mesh of metallic material coupled to an outer surface of the graft material, the mesh having openings therein, the scaffold configured to promote ingrowth of tissue therein, the scaffold containing a ratio of metal to artery optimized to cause blood stasis within the scaffold that causes thrombosis, and wherein the mesh is toroidal in shape, the scaffold having tissue response enhancing fibers embedded therein.

2. The supported stent graft of claim 1, wherein the graft material has a proximal end and a distal end, the scaffold being coupled to the proximal end of the graft material.

3. The supported stent graft of claim 1, further comprising a swelling material coupled to the scaffold.

4. The supported stent graft of claim 1, further comprising a stent ring coupled to the graft material at the support scaffold, the stent ring configured to provide an expansion force greater than a compressive force of a torus.

5. The supportive stent graft of claim 1, wherein the scaffold comprises a tissue healing promoting material coupled to the mesh.

6. The supported stent graft of claim 1, wherein the scaffold comprises a tissue irritating material coupled with the mesh.

7. The stented graft of claim 1, wherein the metallic material comprises a nickel titanium alloy.

8. The supported stent graft of claim 1, wherein the scaffold comprises a thrombogenic material.

9. The supported stent graft of claim 1, wherein the supported stent graft further comprises stitching between the scaffold and the graft material.

10. A supported stent graft, having:

a hydrophobic graft material having a proximal end and a distal end, the graft material providing an environment that is not conducive to cell recruitment and proliferation; and

a scaffold having a mesh of metallic material coupled to an outer surface of the graft material, the mesh having openings therein, the scaffold extending substantially between a proximal end and a distal end of the graft material, the scaffold containing a ratio of metal to artery optimized to cause blood stasis within the scaffold that causes thrombosis, and wherein the mesh is toroidal in shape, the scaffold having tissue response enhancing fibers embedded therein.

11. The stented graft of claim 10, wherein the scaffold is configured to fill an aneurysm sac.

12. The supported stent graft of claim 10, wherein the mesh is tubular.

13. The supportive stent graft of claim 10, wherein the scaffold comprises a tissue healing promoting material coupled to the mesh.

14. The supported stent graft of claim 10, wherein the scaffold comprises a tissue irritating material coupled to the mesh.

15. The supported stent graft of claim 10, wherein the scaffold comprises a thrombogenic material.

16. The supported stent graft of claim 10, wherein the supported stent graft further comprises stitching between the scaffold and the graft material.